Basics 336.003 336AG Medicated Calamine Anti-Itch Lotion

Drug Details [pdf]

CALAMINE- calamine, pramoxine hcl lotion
Amazon.Com Services LLC

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Basics 336.003 336AG
Medicated Calamine Anti-Itch Lotion

Active ingredients

Calamine 8%

Pramoxine HCl 1%

Purpose

Skin protectant

External analgesic

Use

for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac
dries the oozing and weeping of poison:
ivy
oak
sumac

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor

condition worsens
symptoms last more than 7 days or clean up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

shake well
before applying was affected are of skin

Adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

Children under 2 years of age - do not use, ask a doctor

Other information

store at room temperature (59°-77°F)

Inactive ingredients

alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

DISTRIBUTED BY:

Amazon.com, Services, LLC

Seattle, WA 98109

1-877-485-0385

2021 Amazon.com, Inc. or its affiliated.

"Alexa, reorder Amazon Basics Anti-Itch Lotion."

principal display panel

amazon basics

medicated

calamine lotion

External Analgesic/Skin Protectant

Anti-itch lotion

6 FL OZ (177 mL)

image description

CALAMINE
calamine, pramoxine hcl lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-336
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	8.6 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 mg in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ROSEMARY OIL (UNII: 8LGU7VM393)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 72288-336-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2018	09/05/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	05/21/2018	09/05/2024

Labeler - Amazon.Com Services LLC (128990418)

Registrant - Consumer Product Partners, LLC (119091520)

Name	Address	ID/FEI	Business Operations
Establishment
Consumer Product Partners, LLC		119091514	manufacture(72288-336)

Revised: 9/2024

Document Id: 21673169-28b7-0679-e063-6294a90afbee

Set id: 8bdf4fec-f11b-41c3-ba07-efd8d7de36b7

Version: 10

Effective Time: 20240905

Trademark Results [Calamine]

Mark Image Registration \| Serial	Company Trademark Application Date
CALAMINE 86788723 4972728 Live/Registered	Stepanek, Julie 2015-10-15